Associate Director, Benefit Risk Management

Posted on May 14, 2019 by
Jazz Pharma

Palo Alto, CA 94306

Research & Development

Immediate Start

Annual Salary

Full-Time

Overview:

Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.

Our therapeutic areas of focus include sleep and hematology/oncology - areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.

We are looking for the best and brightest talent to join our team. If you're looking to be a part of a company with an unwavering commitment to improving patients' lives and being a great place to work, we hope you'll explore our career openings and get to know Jazz Pharmaceuticals.

Responsibilities:

This position will provide regulatory support for FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) programs in the US, relevant post marketing requirements as well as EX-US risk management activities and initiatives. This individual will lead cross-functional teams and the generation of and analysis of business data for internal review and reporting to government agencies. Lead development of external reports required by governmental oversight bodies as required. Provide guidance to vendors being directly managed by Benefit Risk Management (BRM) Department. Provide necessary training to team members working directly on department initiatives regarding regulatory reports. Support department Director in strategy initiatives and communications to external stakeholders. Support travel needs to support initiative to foster excellence to JPI portfolio managed by BRM team. Work occasionally with external legal guidance partners on matter that involve direct involvement from JPI legal direction for decisions. Participate in designated initiatives to support BRM global expansion. Participate in development and maintenance of dept. and team training materials specifically focused on Risk Management Reports associated with REMS programs.

Essential Functions

Leading role on cross-functional teams for individual and shared REMS programs and EX-US Risk Management Plans

Support strategic initiatives as internal team liaison for information

Work to advance/innovate the science of risk management within the company

Conduct research in support of commercial products and development project as it relates to risk management requirements

Responsible for leading projects with cross-functional involvement

Minimum Requirements

Bachelor's Degree and three or more years of Pharmaceutical experience OR an Advanced degree and six or more months of Pharmaceutical experience or an equivalent combination of education and experience.

Familiarity and exposure to REMS and risk management programs, submissions and implementation - Background in Drug Safety experience will be considered as well

Industry or pharmacy experience working with REMS programs in specialty pharmacies is preferred

Demonstrated business and data analytics abilities

Advanced computer and database skills

Strong communication skills

Ability to work well in a cross-functional team

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.